The Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.
What you will be doing:
What you will be doing:
Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership.
Travel (approximately 5%) domestic and/or international. Anticipated activities may include attendance at kick-off, investigator or study team meetings.
• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
• Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
• For specific projects, serve as the main point of contact with Sponsor, Project Manager, Clinical Trial Manager, Site Activation Lead, other functional leads and third parties. Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
• Assume responsibility as Subject Matter Expert (SME) as required.
• Coordination of all necessary translations required for any start-up documentation.
• Attend study team meetings as required.
• Other duties as assigned
• Responsible, as assigned, for one or more of the following tasks related to each of the key study start-up and/or maintenance activities:
You are:
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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